Life Sciences Translation for Clinical, Regulatory and Medical Device Environments
Inaccurate or inconsistent translation can delay submissions, create compliance issues and impact patient safety. Whether you are preparing an EMA submission, managing a multi-country clinical trial or launching a medical device under MDR, language must be handled with precision and control.
ALM Translations supports pharmaceutical, biotech and medical device organisations with structured, compliant translation processes aligned to regulatory requirements and real-world use.
ALM is both ISO 17100, ISO 9001 and ISAE 3000-part II accredited, which are your guarantees of accuracy, robust processes, security and quality giving you peace of mind that you are in the safest of hands.
Where We Typically Support Clients
We work with life sciences organisations at critical points where translation directly affects timelines, compliance and outcomes:
- Preparing EMA submissions (including QRD templates and MAA documentation)
- Managing multilingual clinical trial documentation across regions
- Supporting EU MDR compliance for medical devices and IFUs
- Translating patient-facing materials and PROs
- Handling regulatory correspondence with global authorities
- Managing adverse event reporting and safety documentation
This approach ensures translation supports progress and not delays.
Clinical Trial Translations
We support global clinical trials with accurate, consistent translation of:
- Ethics committee submissions
- Study protocols and amendments
- Investigator brochures and site documentation
- Informed consent forms (ICFs)
- Patient diaries and questionnaires
Our workflows are designed to support clarity, consistency and regulatory acceptance across all participating countries.
Regulatory Submission Translation (EMA, eCTD, QRD)
Regulatory submissions require precision, consistency and strict adherence to format.
ALM supports:
- Marketing Authorisation Applications (MAA)
- QRD template compliance
- eCTD documentation
- Supporting regulatory correspondence
We ensure terminology consistency across all documents and alignment with regulatory expectations to reduce the risk of delays or rejection.
Medical Device Translation (MDR)
The EU Medical Device Regulation (MDR) places strict requirements on clarity, accuracy and accessibility.
We translate:
- Instructions for Use (IFUs)
- Labelling and packaging
- Technical documentation
- Safety and performance information
Our approach ensures content is consistent, accessible and usable.
Patient-Facing Content & Linguistic Validation
Patient understanding is critical in life sciences.
We support:
- Questionnaires and study materials
- Patient information leaflets (PILs)
- Patient-reported outcomes (PROs)
A Structured, Compliant Approach
ALM’s workflows are designed specifically for regulated environments, with every project supported by specialist life sciences linguists who have relevant academic backgrounds, alongside multi-stage review processes that ensure accuracy and consistency throughout. We utilise terminology management and translation memory to maintain control at scale, with optional back translation available for high-risk content where additional validation is required. Our ISO 17100 and ISO 9001 certifications underpin consistent quality across all projects, while ISAE 3000 provides further assurance around process control and data security.
What You Gain from a Specialist Life Sciences Translation Partner
A partner that understands the unique requirements of the sector
- Reduced risk through compliant translations
- Structured workflows
- Consistency and controlled terminology
Dedicated Project Managers and systems
- Trained in a variety of regulatory content types
- Industry-leading translation memory software is used as standard
- Clear accountability and project control
ISO 17100, 9001 and ISAE 3000-part II accredited
- Subject matter experts with backgrounds in life sciences
- Secure handling of sensitive data
- Multi-stage review and optional back translation
Speak to a Life Sciences Translation Specialist
If you are preparing a submission, running a clinical trial or expanding into new markets, we can support you with a structured, compliant approach to translation. Get in touch to discuss your requirements or request a tailored quote.
Allisone Technologies, an AI SaaS company specialising in dentistry, partners with ALM to localise scientific and marketing content into several languages, paving the way for European market expansion.
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Frequently Asked Questions
In a highly regulated sector like life sciences, details matter and mistakes could result in submissions being rejected or patient safety being compromised. ALM has two decades of experience in the sector, and we use trusted linguists with a background in biology, pharma or chemistry, so you can rest assured that you have subject matter experts working on your texts.
Yes, our translators and in-house project managers are trained and experienced in regulatory submissions applicable to Europe, the US and beyond. This includes centralised procedures (CP), mutual recognition procedures (MRP) and use of the QRD template in the EU, as well as the Electronic Common Technical Document (eCTD) used in the US. ALM staff are trained in the latest developments in these areas.
ALM uses secure file transfer protocols when receiving and delivering your confidential texts, applying best-practice processes for information security, cybersecurity and privacy protection. Our expert translators and project managers are asked to sign strict NDAs to protect both your intellectual property and any patient data (e.g. within clinical trial documents). Our translation systems also employ enterprise-grade security.
In life sciences translation, precision, accuracy and safety are paramount. The scientific terminology used in documentation must be precise and consistent, leaving no room for doubt or confusion. An appropriate register must be used for patient documents to ensure information is accessible. Back translation is also used as the final step in the workflow, as a safety feature to verify accuracy.
Yes, we can handle the additional validation required for translating PROs, specifically the use of cognitive debriefing to ensure that the intended meaning of the original document is appropriately conveyed in the target language. PROs may require significant cultural adaptation and this is where our native-speaking translators, who are also subject matter experts, really add value as language and cultural consultants.
We know that labels used for pharmaceutical products must be clear, unambiguous and consistent while also adhering to strict legal regulations. We have a triple-check translation process, which includes the use of terminology databases for precision, translation memories for consistency and back translation as a final step to ensure that no inaccuracies have been allowed to creep in.
We are fully up to date with the EU Medical Device Regulation (MDR) and how it affects the texts we translate. The regulation includes providing clear language for laypersons who will be using the devices, to ensure they are used as intended, and precise terminology for documentation, reporting and submissions for professionals who manufacture and distribute the devices to EU markets.